Clinical trialPhase 2Not yet recruiting
Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer
Randomized Double-blind, Placebo-controlled, Multicenter Clinical Study of Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer
- Outcome
- Ongoing
- Phase
- Phase 2
- Status
- Not yet recruiting
- Study type
- Interventional
- Start
- 10 December 2025
- Expected end
- 10 December 2029
- Enrollment
- 156 participants
- Sites
- 2
- Primary outcomes
- disease-free survival (DFS)
- Sponsor
- Other
- Results posted
- No
- Last update
- 11 December 2025
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Brief summary public domain (ClinicalTrials.gov)
This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. Led by The First Affiliated Hospital with Nanjing Medical University and Peking University Cancer Hospital \& Institute (as leading centers), its main purpose is to evaluate the clinical efficacy and safety of Nimotuzumab combined with nab-paclitaxel plus gemcitabine (AG) in the perioperative treatment of high-risk resectable/borderline resectable pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
This clinical study is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled trial, led by two leading centers: The First Affiliated Hospital with Nanjing Medical University and Peking University Cancer Hospital \& Institute. Its main purpose is to evaluate the clinical efficacy and safety of Nimotuzumab combined with nab-paclitaxel plus gemcitabine (AG regimen) in the perioperative treatment of high-risk resectable/borderline resectable pancreatic cancer. Approximately 156 patients will be enrolled in this study and randomly assigned in a 1:1 ratio to the experimental group (Nimotuzumab plus AG regimen) and the control group (placebo plus AG regimen). The primary endpoint is disease-free survival (DFS). Secondary endpoints include overall survival (OS), R0 resection rate, preoperative objective response rate (ORR), incidence of postoperative complications, and safety, etc.